ML21083A287
| ML21083A287 | |
| Person / Time | |
|---|---|
| Site: | Hatch, Vogtle, Farley  |
| Issue date: | 03/24/2021 |
| From: | John Lamb Plant Licensing Branch II |
| To: | |
| Lamb J | |
| References | |
| Download: ML21083A287 (14) | |
Text
Pre-Submittal Meeting - Quality Assurance Topical Report Revision to Allow Application of Remote Assessment Techniques During Exigent Conditions March 2021
2 Meeting Purpose and Agenda
- The purpose of this meeting is to discuss a proposed revision to the Southern Nuclear Operating Company (SNC) Quality Assurance Topical Report (QATR) o This revision is considered a commitment reduction within the quality assurance program and requires submittal to NRC for approval per 10 CFR 50.54(a)(4).
o This revision incorporates use of EPRI Technical Report 3002020796, Remote Assessment Techniques: Planning and Conducting Audits and Surveys Utilizing Remote Techniques During Exigent Conditions.
Agenda
Background:
o Requirements o Hardship due to Pandemic
- Submittal Details:
o Proposed QATR Changes o Submittal Content o Timing
- Comments/Questions
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Background===
4 Background
- Vendor audits are to be completed on a 36-month frequency
- Most utilities have adopted an NRC-approved SER that allows for a 25% (i.e., 9 months) grace period to complete an audit beyond the 36-month period
- Most vendor audits are coordinated through NUPIC and adhere to NUPIC and EPRI guidance, utilizing a performance-based approach o Performance-based auditing involves direct observation at the vendor facility o Common interpretation of Appendix B Criterion VII is that supplier audits must be conducted at the vendor facility
5 Current SNC QATR Requirements
- ASME NQA-1-1994, Quality Assurance Requirements for Nuclear Facility Applications Basic Requirement 7 Control of Purchased Items and Services, Supplement 7S-1 Supplementary Requirements for Control of Purchased Items and Services, Section 3 Supplier Selection, Sub-Section 3.1 Source Evaluation and Selection includes language that states in part:
- Background and Objective Measures for evaluation and selection of procurement sources, and the results therefrom, shall be documented and shall include one or more of (a) through (c) below:...
(c) Suppliers technical and quality capability as determined by a direct evaluation of his facilities and personnel and the implementation of his quality assurance program.
In this context, direct evaluation is interpreted as implying evaluation at the facility being assessed.
6 Current SNC QATR Requirements
5.2.13.1(3) - Source Inspection and Audit. Provisions for access to the supplier's facilities and records for source inspection and audit when the need for such inspection or audit has been determined.
o 5.2.13.2 - Control of Purchased Material, Equipment and Services. Measures shall be provided to assure that purchased items and services, whether purchased directly or through contractors, conform to the procurement documents. These measures shall include provisions, as appropriate, for source evaluation and selection, objective evidence of quality furnisher by the contractor, inspection and audit at the source and examination of items upon delivery.
- Regulatory Guide 1.28, Revision 3, August 1985 - Quality Assurance Program o
3.2, 1. - The applicant or licensee should either audit its supplier's quality assurance program on a triennial basis or arrange for such audit.
7 Background - Hardship due to Pandemic
- COVID-19 related travel restrictions, both domestic and international, are precluding the ability of station QA personnel from conducting audits of vendors required by Criteria VII and XVIII of Appendix B and utility QA plans.
o Personnel travel is challenged across state and international lines o Some suppliers are restricting access to their facility
- There are two examples where international suppliers have expired in the industry due to international travel restrictions.
QATR Revision Details
9 Proposed QATR Change
- This request is for adopting EPRI Document - 3002020796 - Use of Remote Assessment Techniques: Planning and Conducting Audits and Surveys Utilizing Remote Techniques During Exigent Conditions, which is applicable to the Southern Nuclear Fleet (Farley, Hatch and Vogtle).
- The proposed change, though considered a reduction in commitments, will provide additional flexibility for SNC to perform vendor assessments using one of the following techniques:
o Provisional remote assessments, where all assessors are remote, can be used in cases where on-site in person presence is necessary, but is not possible due to exigent conditions. The results of a provisional remote assessment are evaluated to determine if approval of the assessed organization can be provisionally renewed with appropriate restrictions applied to each order during the provisional approval period.
o Fully remote assessments, where all assessors are remote, can be used in limited cases when on-site presence is not necessary, such as when the supplier does not have a production facility.
10 QATR Revision Change 1
- A new bullet will be included in Section 7.2 for the clarifications and exceptions:
Within Requirement 7S-1, the terms direct evaluation and audit may be satisfied using remote assessment techniques in pandemic or exigent conditions.
o Pandemic and Exigent Conditions In the case of Pandemic or exigent Conditions, SNC is adopting EPRI Document - 3002020796 - Use of Remote Assessment Techniques: Planning and Conducting Audits and Surveys Utilizing Remote Techniques During Exigent Conditions, to be used to assess suppliers Quality Assurance programs.
11 QATR Revision Change 2 Part III Regulatory Commitments will be revised as follows:
- Regulatory Guide 1.28, Revision 3, August 1985 - Quality Assurance Program Requirements (Design and Construction)
- Southern Nuclear meets the requirements of this regulatory guide for Construction Activities conducted by Southern Nuclear, except that ASME NQA-1-1994 edition (as modified by the exceptions to NQA-1-1994 as shown in this QATR) will be used in place of ANSI/ASME NQA-1-1983 and the ANSI/ASME NQA-1a-1983 Addenda. Within Regulatory Guide 1.28, the terms direct evaluation and audit may be satisfied using remote assessment techniques in pandemic or exigent conditions.
12 Hybrid Audit Method Discussion
- EPRI 3002020796 also contains guidance for the conduct of hybrid assessments
- Based on preliminary 50.54(a) evaluations, the use of this method has been determined to not be in conflict with 10 CFR Appendix B nor a reduction to SNC QATR commitments
- No explicit QATR changes are proposed to address use of the hybrid assessment approach
- For ease of NRC review and end user use, the entire EPRI document will be transmitted in the request for NRC review, however only the portions of the document related to fully remote and provisional remote assessment methods during exigent circumstances are being adopted into the SNC QATR for which NRC review and approval is requested.
13 Submittal Content
- Submittal per 50.54(a)(4) o Forwarding Letter (NL-21-0051)
- Will address anticipated use by multiple utilities and suppliers o Enclosure 1 - Description and Justification for Change
- Attachment 1 - Markup of QATR Page
- Attachment 2 - Clean-Typed QATR Page o Enclosure 2 - EPRI Technical Report 3002020796, Use of Remote Assessment Techniques: Planning and Conducting Audits and Surveys Utilizing Remote Techniques During Exigent Conditions
- Timing o Anticipate EPRI issuance of 3002020796 mid-April 2021 o Targeting SNCs QATR change submittal approximately three weeks after EPRIs issuance of 3002020796
Questions?